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Thanks to technological breakthroughs, sponsors are developing more novel therapeutics for the CNS than ever – some targeting the most lethal conditions. The global market for CNS therapeutics was worth an estimated $144.3 However, the advanced nature of the drugs being developed has brought new challenges.
Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. Do you need a pharmacokinetic study?
The regulatory environment in Japan for generic drugdevelopment is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.
In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drugdevelopers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-.
These guidances are designed to streamline the development process and help ensure that generic drugs meet the same high standards of safety and efficacy as their brand-name counterparts. They offer guidance on formulation development and manufacturing considerations.
The GEMZ study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center clinical trial designed to assess the safety, efficacy, and pharmacokinetics of fenfluramine in children and adults aged 1 to 35 years diagnosed with CDD who experience uncontrolled seizures.
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drugdevelopment due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.
Listen to the audiobook or download the PDF below, to learn more about: key factors to consider in drugdevelopment (age, biological sex, genetics, DDIs); examples of common DDI involving the cytochrome P450 enzyme system; and drug interactions and guidance for marketeddrugs. The Altascientist, Issue 7, pg.
Drugdevelopment is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.
These interactions can alter the pharmacological activity of one or more drugs, potentially leading to diminished therapeutic effects or unexpected toxic reactions. DDI can occur through multiple mechanisms, including alterations in drug absorption, distribution, metabolism, and excretion.
New drugdevelopment is a long and expensive process that can be fraught with obstacles, including unexpected delays, poor efficacy results, safety issues, or regulatory challenges. The need for difficult decisions The latest estimates on the median cost of bringing a new drug to market is now $2.3
Benefits of the Portfolio-Centric Approach Risk mitigation Increased profitability Broader market presence Therapeutic Area Dominance Some manufacturers are choosing to become the Gordon Ramsay of specific therapeutic areas. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?
MENU logo-altasciences EN - Main navigation Proactive DrugDevelopment Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution Business Leaders (..)
Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drugdevelopment lifecycle. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.
Srijit Seal, a visiting scholar at the Carpenter-Singh Lab in the Broad's Imaging Platform , trained multiple predictive machine learning models to identify chemical and structural drug features likely to cause toxic effects in humans. Pharmacokinetic modeling is difficult, time-consuming, and requires expensive instruments and software.
In this blog, we explain the role of clinical pharmacology in drugdevelopment and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.
Advances in predictive modeling, high-throughput screening, and omics technologies have provided powerful tools to uncover safety risks early in the drugdevelopment pipeline. Addressing safety issues early in the pipeline is essential to improving efficiency and reducing the risks associated with development.
Accelerating Global DrugDevelopment Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Image Social media_e-bulletin Ethnobridging.jpg Tags Clinical Trials Weight 1
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Let’s delve into what lies ahead in the coming year.
Drug discovery is an interdisciplinary process that relies heavily on expert input from diverse and multifaceted teams, from medicinal, synthetic, and computational chemists to biologists and drug metabolism and pharmacokinetics (DMPK) scientists.
The pharmaceutical industry is under huge pressure to address the high attrition rates in drugdevelopment. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).
In some cases, the FDA has had to remove approvals of oncology drugs based on single-arm trials after they came to market because confirmatory studies had found that the safety/tolerability profile was less acceptable in the wider population.
Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drugdevelopment comes with its own set of clinical development requirements. Watch the video. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here. Watch it now.
In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drugdevelopment. 2018;10(4):539–46. Harth S, Frisch C. 2021;291–306.
The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drugdevelopment. This necessitates exploring alternative strategies to expedite drug discovery and optimize resource allocation.
The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The new formulation resulted in a drug product that was very viscous. Human factors.
The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.
The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.
“These positive Phase II results are promising and pave the way for further evaluation of oral LNP023 as a potential monotherapy treatment and standard of care for PNH,” said John Tsai, Head Global DrugDevelopment and Chief Medical Officer, Novartis. “We
Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.
How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drugdevelopers has changed. The generic drug user fee program is currently on its third iteration (i.e.,
The recommendations apply to a wide range of application types, including Investigational New Drugs (INDs) or Investigational Device Exemptions (IDEs), as well as any product “for which clinical studies are intended to support a marketing submission.” The law directed the FDA to “update or issue guidance” on diversity action plans.
Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.
By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drugdevelopment A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.
To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.
Opinions regarding how the new act will impact the industry vary, with predictions ranging from everything remaining at the status quo to the end of animal testing for new drugdevelopment and approvals. Synthroid® oral tablets) were marketed as unapproved drugs for the treatment of hypothyroidism in the US.
To address these challenges, governments and organizations have introduced financial incentives, such as grants, tax credits, and market entry rewards. Public-private partnerships fund critical research efforts, such as the Global Antibiotic Research and Development Partnership , which funds essential research efforts.
Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. These are just some examples that highlight the critical importance of diversity in clinical trial data for the medicines reaching the market.
DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. A sponsor could conduct a study that is not initially viewed as pivotal but which ends up being so for its marketing application.
Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market. The drugdevelopment industry is undoubtedly in a season of change.
For example, a letter from Massachusetts Senator Ed Markey called on FDA to “enhance post-market surveillance of opioids, including by conducting regular, formal reviews of opioid approvals,” among other regulatory activities. Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ].
Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. The safety and tolerability of aducanumab was the primary aim of the study. About Alzheimer’s Disease.
A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. Other guidances of note include one on the “study of sex differences in the clinical evaluation of medical products.”
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